NCT01072175 · OUTCOME
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
What was measured
For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Analysis population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Groups in this outcome
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 23 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 27 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 94 |
|---|
Reported measurements
Basophils
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 4 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 9 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Eosinophils
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 10 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 13 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 39 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Hematocrit
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 5 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 9 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 26 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Mean Corpuscle Hemoglobin concentration
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 10 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 16 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 34 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Mean Corpuscle Hemoglobin
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 9 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 14 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 23 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Mean Corpuscle Volume
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 7 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 10 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 18 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Monocytes
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 3 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 12 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 19 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 51 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Red Blood Cell count
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 9 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 6 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 27 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Reticulocytes
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 4 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 8 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 11 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 9 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 7
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 9
- units
- Participants
- title
- Basophils
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 28
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 11
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 39
- units
- Participants
- title
- Eosinophils
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 24
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 26
- units
- Participants
- title
- Hematocrit
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 21
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 13
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 34
- units
- Participants
- title
- Mean Corpuscle Hemoglobin concentration
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 12
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 11
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 23
- units
- Participants
- title
- Mean Corpuscle Hemoglobin
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 18
- units
- Participants
- title
- Mean Corpuscle Volume
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 21
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 30
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 51
- units
- Participants
- title
- Monocytes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 25
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 27
- units
- Participants
- title
- Red Blood Cell count
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 9
- units
- Participants
- title
- Reticulocytes
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 94
- units
- Participants
- description
- For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
- groups
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
- id
- OG000
- title
- Part B: Dabrafenib 75 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG001
- title
- Part B: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG002
- title
- Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
- description
- Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
- id
- OG003
- title
- Part B: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
- title
- Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
Triangle